EMEA-002722-PIP01-19-M02
Key facts
Active substance |
Etranacogene dezaparvovec
|
Therapeutic area |
Haematology-Hemostaseology
|
Decision number |
P/0380/2022
|
PIP number |
EMEA-002722-PIP01-19-M02
|
Pharmaceutical form(s) |
Concentrate for solution for infusion
|
Condition(s) / indication(s) |
Treatment of Haemophilia B
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
CSL Behring GmbH
Email: PIP.CSLBehring@cslbehring.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|